Shares of small-cap penny stock Soleno Therapeutics, Inc. (NASDAQ: SLNO) shares are trading higher after the company provided a regulatory update following recent communications with the FDA regarding the development of DCCR for the treatment of Prader-Willi syndrome.
Earlier this year, Soleno submitted a proposal to add a randomized withdrawal period to Study C602 in order to obtain additional controlled data requested by the FDA to support an NDA.
The FDA acknowledged that data from a proposed randomized withdrawal phase of Study C602 would have the potential to address its concerns regarding the adequacy of the overall efficacy data supportive of a new drug application submission for DCCR, said in the company's press release.
Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics, said "We are pleased to continue our constructive dialogue with the FDA. This randomized withdrawal period may enable us to obtain the data needed to support an NDA in an efficient and timely manner."
Soleno Therapeutics Inc is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.
The stock was trading 15.5% higher at $0.22 per share on Wednesday at the time of publication, according to data from Benzinga Pro.
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